Source: 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE MKT:XXII),
a leader in tobacco harm reduction, announced that The New England
Journal of Medicine has published a special article describing a
milestone study that used the Company’s proprietary SPECTRUM research
cigarettes (N
Engl J Med 2015; 373:1340-1349).
The Center for the Evaluation of Nicotine in Cigarettes led the
double-blind, parallel, randomized clinical trial involving 840 smokers
at ten locations. The authors concluded that data from the study
suggests, as compared with cigarettes of conventional nicotine content,
22nd Century’s proprietary low nicotine SPECTRUM cigarettes were
“associated with reductions in smoking, nicotine exposure, and nicotine
dependence, with minimal evidence of nicotine withdrawal, compensatory
smoking, or serious adverse events.”
he study, which was funded by the National Institute on Drug Abuse
(NIDA) and the U.S. Food and Drug Administration (FDA) Center for
Tobacco Products, included six styles of 22nd Century’s SPECTRUM
research cigarettes. The SPECTRUM cigarettes had nicotine contents
ranging from 15.8 mg per gram of tobacco (similar to commercial brands)
to 0.4 mg per gram (“very low nicotine”). The very low nicotine SPECTRUM
cigarettes contain 95% less nicotine than conventional cigarettes. 22nd
Century is the only company in the world capable of growing tobacco with
such low nicotine content.
Researchers found that during the 6th and final week of the trial,
participants who were assigned 22nd Century SPECTRUM cigarettes with 0.4
mg/g nicotine smoked fewer cigarettes per day (14.9) than those assigned
to their usual brand (22.2). In fact, very low nicotine cigarettes were
found to reduce exposure to, and dependence on, nicotine and to reduce
cravings while adverse events were generally mild and similar among
groups. Moreover, in the 30 days following the trial, smokers of very
low nicotine cigarettes reported they attempted to quit smoking at a
rate double that of participants who smoked cigarettes with 15.8 mg/gram
nicotine (34.7% vs. 17%).
The study’s lead author, Dr. Eric Donny, explained in an article posted
on usatoday.com, "The evidence is getting stronger that reducing
nicotine reduces smoking and makes people less addicted to cigarettes
and, in doing so, might make them more likely to quit." To further test
this theory, 22nd Century’s proprietary SPECTRUM cigarettes are being
used in a Phase III clinical study that follows 1,250 smokers for five
months (ClinicalTrials.gov
NCT02139930).
The results of previous
studies using very low nicotine cigarettes have demonstrated a host
of desirable outcomes including reduced smoking, reduced nicotine
exposure, reduce nicotine dependence, increased abstinence, reduced
exposure to toxicants and few adverse events with little evidence of
withdrawal-related discomfort or safety concerns. Unlike “light”
cigarettes (as previously labeled and marketed by conventional tobacco
companies) which reduce machine-smoking nicotine yields by diluting the
smoke rather than by reducing the nicotine content of the tobacco
itself, very low nicotine cigarettes do not result in compensatory
smoking.
In the past 8 years, the prospect of reducing the addictiveness of
cigarettes has received renewed attention from numerous health
organizations, including the Institute of Medicine, the World Health
Organization (WHO) and the Office of the U.S. Surgeon General. The
Tobacco Control Act, enacted in 2009, granted the FDA authority to set
standards that reduce the nicotine content of all cigarettes sold in the
United States.
“The current study by Donny and colleagues adds to a growing literature
supporting the feasibility and potential benefits of a national nicotine
reduction policy…” explained public health policy reform advocates, Drs.
Michael Fiore and Timothy Baker in a companion article in the same issue
of the NEJM. “Reducing the nicotine content of combustible tobacco to
levels that will not sustain dependence seems to us to be the most
promising regulatory policy option for preventing [at least] 20 million
premature deaths.”
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of nicotine
in tobacco plants through genetic engineering and plant breeding. The
Company’s mission is to reduce the harm caused by smoking. 22nd Century
currently owns or exclusively controls more than 185 issued patents and
more than 50 pending patent applications around the world. The Company’s
strong IP position led to a licensing agreement with British American
Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com
for more information.
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